Reduced relapse rate
Olanzapine maintenance treatment significantly reduces rates of manic and depressive relapse
Lilly’s claim that olanzapine has efficacy in maintenence therapy is based on one randomized, placebo-controlled trial in which the drug demonstrated efficacy in preventing relapse into both manic and depressive episodes. FDA approval of a maintenance extension of the indication of olanzapine for acute mania was based on this trial. An additional maintenance study of olanzapine versus lithium showed some areas of superiority of olanzapine over lithium, especially in prevention of a manic relapse. GSK counterclaim: Olanzapine has never been studied as a maintenance treatment in patients who were initially depressed at study entry. Food and Drug Administration
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